Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Gray Sheet

Executive Summary

BAXTER MODIFIES EXAM GLOVE SAMPLING PLAN WRITTEN PROCEDURES at its Eaton, Ohio manufacturing plant in response to a March 17 warning letter from FDA. The company says it informed FDA in a March 25 response to the warning letter that it has clarified written procedures for its sampling plan in order to address the good manufacturing process violations outlined in FDA's letter. According to FDA's letter, the company failed "to assure that sampling plans for checking, testing, and release of a device are based on an acceptable statistical rationale." For example, FDA states that a certain quality assurance test was "not defined by an inspection frequency which is statistically determined." In response, Baxter has modified the written procedure explicitly to state the statistical rationale for the sampling process. A second sampling-related violation noted by FDA is the company's "failure to assure that all quality assurance checks are appropriate and adequate...and are performed correctly." FDA notes that "in-process inspections" do not follow the firm's procedure for random and multiple sample selection methods. The firm says that the sampling procedure, which had been intended as a general guideline, has been rewritten to clarify sample selection methodology. The firm has assured FDA that it will maintain records that document each time the dip tank protective screen is removed and changed. This action responds to an agency citation that the firm failed "to maintain a written record documenting when scheduled maintenance activities are performed." In the warning letter, FDA notes that Baxter did not "assure that all production and quality assurance equipment is routinely calibrated, inspected and checked," and cites temperature instruments that were "not calibrated within the established interval." Baxter says it is addressing this notation by monitoring two infrared temperature instruments under its quality assurance calibration program; the instruments were previously checked under the company's routine maintenance calibration program, which allowed for fewer calibrations. A March 17 warning letter issued to Puritan-Bennett cites GMP violations at the firm's Tijuana, Mexico manufacturing facility that were discovered during a routine inspection on November 16-18. FDA says that the company did not "investigate complaints involving the possible failure of a device to meet...performance specifications." The agency cites three complaints involving either "unexpected high temperature readings or leaking bacterial filters" that were not investigated. The agency also states that the company failed to maintain duplicate copies of investigation complaint records at the "actual manufacturing establishment in a file designated for device complaints," as required by GMP regulations. FDA cites as examples two complaints which had not "been transmitted from the Carlsbad, California facility" to the Tijuana plant. The company says that it has not yet received FDA's warning letter.

You may also be interested in...

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 

Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers

US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts